Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME) (CIME)

• ClinicalTrials.gov Identifier: NCT01595984
• Recruitment Status: Unknown
• First Posted: May 10, 2012
• Last Update Posted: August 21, 2018
• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: Novartis
• Information provided by (Responsible Party): Centre Hospitalier Universitaire, Amiens

Study Description

Brief Summary:

The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.

Renal function will be accurately evaluated by measuring the clearance of iohexol.

The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.

Condition or disease	Intervention/treatment	Phase
Kidney Failure	Drug: cyclosporin + mycophenolate mofetil; Drug: everolimus + mycophenolate mofetil	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant
• Actual Study Start Date: May 3, 2012
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: August 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cyclosporin + Mycophenolate mofetil	Drug: cyclosporin + mycophenolate mofetil; antirejection drug, renal transplantation
Experimental: Everolimus + mycophenolate mofetil	Drug: everolimus + mycophenolate mofetil; antirejection drug, renal transplantation

Outcome Measures

Primary Outcome Measures :

1. Evolution of glomerular filtration rate measured by clearance of iohexol [ Time Frame: one year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males and Females aged between 18 and 70.
• Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
• Patient with a maximum PRA <20%.
• Patient wishing and being able to participate fully to the study, and having given a written consent.
• Patient covered by a social insurance or beneficiary of such a regime.
• Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.

Exclusion Criteria:

• Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
• Patient with a maximum PRA> 20% twice.
• Cold ischemic time > 36 hours.
• Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
• Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
• Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
• Patient with severe systemic infections requiring continued therapy.
• Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
• Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
• Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.
• Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
• Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
• Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
• Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
• Patient under guardianship, or any patient protected by law.

Contacts and Locations

Locations

France

Nephrology department, Hospital University of Amiens

Amiens, France, 80000

Nephrology Department, University Hospital of Montpellier

Montpellier, France, 34285

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Novartis

More Information

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT01595984
• Other Study ID Numbers: PI10-PR-CHOUKROUN; 2011-001385-18 ( EudraCT Number )
• First Posted: May 10, 2012
• Last Update Posted: August 21, 2018
• Last Verified: August 2018

Keywords provided by Centre Hospitalier Universitaire, Amiens:

kidney; transplantation; graft; creatinin

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Antineoplastic Agents; Antibiotics, Antineoplastic; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents